Improvement in congestion and other defining nasal symptoms

The efficacy of XHANCE was evaluated in NAVIGATE I and NAVIGATE II: Two similar Phase 3 pivotal randomized, placebo-controlled, multicenter studies (n=646).1,2

Congestion — Coprimary Endpoint1,2

Line graph showing the least-squares mean change in congestion score vs baseline for XHANCE and placebo
Line graph showing the least-squares mean change in congestion score vs baseline for XHANCE and placebo

*Least-squares mean change from baseline in patient-reported AM instantaneous diary scores for nasal symptoms on a scale from 0-3 (0 = none, 1 = mild, 2 = moderate, 3 = severe).

Results shown above are from NAVIGATE II and are consistent with results observed in patients participating in NAVIGATE I.1,3

The comparator used in the pivotal clinical studies was a liquid placebo delivered with an Optinose Exhalation Delivery System (EDS).1

 

XHANCE clinical trial design

XHANCE has been extensively studied in over 1600 patients

Phase 3 Trials Demonstrating Efficacy and Safety
Two similar randomized, placebo-controlled multicenter studies to assess XHANCE safety and efficacy (N=646).1,2

Flow chart showing the study design and clinical trial format for NAVIGATE I and NAVIGATE II Flow chart showing the study design and clinical trial format for NAVIGATE I and NAVIGATE II

NAVIGATE I: placebo EDS, n = 82; XHANCE 186 mcg BID, n = 80; XHANCE 372 mcg BID, n = 80.
NAVIGATE II: placebo EDS, n = 80; XHANCE 186 mcg BID, n = 80; XHANCE 372 mcg BID, n = 82.

Coprimary endpoints1,2:

  • Reduction of nasal congestion/obstruction symptoms at Week 4
  • Reduction in total polyp grade at Week 16

Secondary endpoints include1,2:

  • Change from baseline in nasal congestion/obstruction, sense of smell, rhinorrhea, and facial pain or pressure
  • Subject assessment of Patient Global Impression of Change (PGIC) at Week 16
  • Secondary endpoints were not controlled for Type I error

Key inclusion criteria1,2:

  • Bilateral nasal polyps (grade 1 to 3)
  • Moderate to severe symptoms of nasal congestion/obstruction

Details1,2:

  • A liquid placebo comparator was delivered using an Optinose Exhalation Delivery System (EDS)
  • In the pivotal clinical trials, 91% of patients reported previous use of a nasal steroid for the treatment of nasal polyps, and 54% reported previous sinus surgery or polypectomy
  • Patients and physicians remained blinded to initial treatment throughout the 8-week open-label extension
  • Patients with history of allergic rhinitis could participate in the study provided their “season” did not coincide with the first 4 weeks of the study
  • Subjects were allowed to use nonsedating antihistamines as “rescue” after Week 4 in an effort to reduce placebo dropout

 

References:
  1. Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2017.
  2. Data on file. OptiNose US, Inc.

 


 

Statistically significant onset of action was generally observed within 2 weeks for congestion score.1

Sense of Smell – Secondary Endpoint2‡

Line graph showing the least-squares mean change in sense of smell score vs baseline for XHANCE and placebo
Line graph showing the least-squares mean change in sense of smell score vs baseline for XHANCE and placebo

Pain and Pressure – Secondary Endpoint2‡

Line graph showing the least-squares mean change in pain and pressure score vs baseline for XHANCE and placebo
Line graph showing the least-squares mean change in pain and pressure score vs baseline for XHANCE and placebo

Rhinorrhea — Secondary Endpoint2‡

Line graph showing the least-squares mean change in rhinorrhea score vs baseline for XHANCE and placebo
Line graph showing the least-squares mean change in rhinorrhea score vs baseline for XHANCE and placebo

*Least-squares mean change from baseline in patient-reported AM instantaneous diary scores for nasal symptoms on a scale from 0-3 (0 = none, 1 = mild, 2 = moderate, 3 = severe).

Results shown above are from NAVIGATE II and are consistent with results observed in patients participating in NAVIGATE I.1,3

Multiplicity adjustments were not applied for secondary endpoints; therefore, results require cautious interpretation and could potentially represent chance findings.

 

XHANCE clinical trial design

XHANCE has been extensively studied in over 1600 patients

Phase 3 Trials Demonstrating Efficacy and Safety
Two similar randomized, placebo-controlled multicenter studies to assess XHANCE safety and efficacy (N=646).1,2

Flow chart showing the study design and clinical trial format for NAVIGATE I and NAVIGATE II Flow chart showing the study design and clinical trial format for NAVIGATE I and NAVIGATE II

NAVIGATE I: placebo EDS, n = 82; XHANCE 186 mcg BID, n = 80; XHANCE 372 mcg BID, n = 80.
NAVIGATE II: placebo EDS, n = 80; XHANCE 186 mcg BID, n = 80; XHANCE 372 mcg BID, n = 82.

Coprimary endpoints1,2:

  • Reduction of nasal congestion/obstruction symptoms at Week 4
  • Reduction in total polyp grade at Week 16

Secondary endpoints include1,2:

  • Change from baseline in nasal congestion/obstruction, sense of smell, rhinorrhea, and facial pain or pressure
  • Subject assessment of Patient Global Impression of Change (PGIC) at Week 16
  • Secondary endpoints were not controlled for Type I error

Key inclusion criteria1,2:

  • Bilateral nasal polyps (grade 1 to 3)
  • Moderate to severe symptoms of nasal congestion/obstruction

Details1,2:

  • A liquid placebo comparator was delivered using an Optinose Exhalation Delivery System (EDS)
  • In the pivotal clinical trials, 91% of patients reported previous use of a nasal steroid for the treatment of nasal polyps, and 54% reported previous sinus surgery or polypectomy
  • Patients and physicians remained blinded to initial treatment throughout the 8-week open-label extension
  • Patients with history of allergic rhinitis could participate in the study provided their “season” did not coincide with the first 4 weeks of the study
  • Subjects were allowed to use nonsedating antihistamines as “rescue” after Week 4 in an effort to reduce placebo dropout

 

References:
  1. Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2017.
  2. Data on file. OptiNose US, Inc.

 

Examine the effect of XHANCE on bilateral polyp grade.1
References:
  1. Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2017.
  2. Leopold DA, Elkayam D, Messina JC, et al. NAVIGATE II: randomized double-blind trial of the exhalation delivery system with fluticasone (EDS-FLU) for nasal polyposis. J Allergy Clin Immunol. 2018; In press.
  3. Data on file. OptiNose US, Inc.